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Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborators:
The Cleveland Clinic
University Hospitals of Cleveland
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01996852
First received: November 22, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 180 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.


Condition Intervention
Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction Following Simple Prostatectomy
Erectile Dysfunction
Behavioral: Cognitive-behavioral Meetings
Drug: sildenafil citrate
Device: Vacuum Constriction Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Erectile Function Improvement [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 10 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.

  • Change in Number of Erections [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.

  • Erectile Function Improvement [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 7 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.

  • Change in Number of Erections [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.


Secondary Outcome Measures:
  • Sexual Quality of Life (QoL) Improvement [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the total score of the Sexual Quality of Life (male/female) scales. Higher scores indicate better quality of life.

  • Change in Overall Quality of Life (QoL) Score [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.

  • Improved Mood Score [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the sub-score from the 21-item Profile of Mood States (POMS) will be used to measure psychological adjustment to cancer. It will be used to measure depression, anxiety and anger. Higher scores indicate more mood disorder.

  • Change in Treatment Compliance [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.

  • Change in Frequency of Sexual Activity [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days

  • Change in Frequency of Sexual Activity [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days

  • Change in Treatment Compliance [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.

  • Sexual Quality of Life (QoL) Improvement [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the total score of the Sexual Quality of Life (male/female) scales

  • Change in Overall Quality of Life (QoL) Score [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.


Other Outcome Measures:
  • Self-Efficacy Improvement [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.

  • Self-Efficacy Improvement [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.

  • Change in Level of Sensual Pleasure of Sex [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.

  • Change in Level of Sensual Pleasure of Sex [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.

  • Change in Perceived Partner Support [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    change from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.

  • Change in Perceived Partner Support [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    change from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.

  • Change in Flaccid Penile Length [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Change from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method

  • Change in Flaccid Penile Length [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Change from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method

  • Change in Stretched Penile Length [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Change from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method

  • Change in Stretched Penile Length [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Change from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method

  • Change in Volume of Flaccid Penile Blood Flow [ Time Frame: 7 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries

  • Change in Volume of Flaccid Penile Blood Flow [ Time Frame: 10 months after start of treatment ] [ Designated as safety issue: No ]
    Change from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries

  • TGF-B1 Levels [ Time Frame: baseline - 1 week after start of treatment ] [ Designated as safety issue: No ]
    Total level of Transforming Growth Factor Beta-1 levels will be assessed using a commercially available assay


Estimated Enrollment: 180
Study Start Date: July 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard ED Care
Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)
Drug: sildenafil citrate

100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.

To increase external validity, participants will be given the choice of using Sildenafil in the study.

Other Name: Viagra
Device: Vacuum Constriction Device

The medical treatment entails a 10-minute daily use of VCD (pump).

The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call.

Other Names:
  • VCD
  • Pump
Experimental: Standard ED Care + Cognitive-Behavioral Intervention
standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings
Behavioral: Cognitive-behavioral Meetings

The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.

Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.

Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min.

Drug: sildenafil citrate

100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.

To increase external validity, participants will be given the choice of using Sildenafil in the study.

Other Name: Viagra
Device: Vacuum Constriction Device

The medical treatment entails a 10-minute daily use of VCD (pump).

The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call.

Other Names:
  • VCD
  • Pump

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage I, II, and III prostate cancer ages 21 and over;
  • Having completed definite treatment of localized prostate cancer (surgery or radiation);
  • Presence of erectile dysfunction symptoms;
  • Have a stable partner for six months who is willing to participate;
  • Sexually active prior to cancer treatment (≥17 on the Sexual Health Inventory For Men― ("SHIM")).
  • Bilateral nerve-sparing prostatectomy with or without radiation for the pilot study patients only.

Exclusion Criteria:

  • Receiving hormonal treatment;
  • Cognitive impairment (≥5 on the Short Portable Mental Status Questionnaire (SPMSQ));
  • Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (<85 on the Locke-Wallace Marital Adjustment Test);
  • Taking nitrates of any kind;
  • Congenital bleeding disorder or predisposition to priapism that is contraindicative to VCD use;
  • Having untreated clinical depression and other psychotic mental disorders (e.g., bipolar, schizophrenia) (≥27 on the Center for Epidemiological Studies Depression Scale (CES-D)).
  • Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc).
  • Patients taking concomitant alpha-adrenergic blocking agents.
  • Patients with a clinically significant abnormality on screening ECG (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient's cardiovascular risk in this study.
  • Patients with a history of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).
  • Patients with a history of severely impaired autonomic control of blood pressure.
  • Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg) at Screening.
  • Patients with known hypersensitivity to sildenafil or other ingredients of Sildenafil.
  • Patients with retinitis pigmentosa.
  • Patients with active peptic ulceration.
  • Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).
  • Patients taking other phosphodiesterase Type 5 (PDE5) inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996852

Contacts
Contact: Amy Zhang, MD 216-368-0968 axz16@case.edu
Contact: Eric Klein, MD kleine@ccf.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Amy Zhang, MD         
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Eric Klein, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
The Cleveland Clinic
University Hospitals of Cleveland
Investigators
Principal Investigator: Amy Zhang, MD Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01996852     History of Changes
Other Study ID Numbers: CASE14812, 05-12-05C
Study First Received: November 22, 2013
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
Erectile dysfunction
ED
Prostate
Prostatectomy

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014